Water Sampling and Testing

Water is the most common raw material used to manufacture medicine, devices, or nutritional products. The United States Pharmacopeia (USP) defines several types of water including: Purified Water, Water for Injection, Sterile Purified Water, Sterile Water for Injection, Sterile Bacteriostatic Water for Injection, Sterile Water for Inhalation, and Sterile Water for Irrigation. However, there are two basic types of water preparation, Water for Injection (WFI) and Purified Water. The analytical standards for these two types of water are very similar, differing in the fact that Water for Injection has stricter bacterial count standards and must also pass the bacterial endotoxin test.

The source water supplied to the purification system for preparation of USP water must comply with drinking water standards as defined by the United States Environmental Protection Agency in the National Primary Drinking Water Regulations or equivalent international regulations. Although the water source must be safe to drink, there is quite a range of problematic contaminants that may be present in the water. Chlorine is most certainly present in the water and will have to be removed at some point in the purification process.

The following tests are required to meet USP and EP test requirements: Conductivity, Total Organic Carbon (TOC), and Bioburden (plus bacterial endotoxin in the case of WFI Water used to manufacture products for Europe must meet EP test requirements for heavy metals and nitrates.

Microbiology & Quality Associates (MQA) provides sampling, and microbiological and chemical testing services for water systems 7 days a week.

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